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Abstract

Abstract CellSight is a clinical stage company developing PET imaging tools that can increase the probability of clinical success of immunotherapies by determining early in the therapeutic regimen if the cancer patient is responding to their immunotherapy. Cancer immunotherapies that harness the body's immune system to help fight cancer do not work for everyone; in fact, success rates can be as low as 20%. This means that up to 80% of patients undergoing immunotherapy are spending over $100,000 and investing 6 to 10 months on ineffective treatments. Our lead imaging tracer, [18F]-FAraG product named VisAcT, leverages existing health and PET imaging infrastructure but is specific for visualizing immune response. This whole body visualization will provide clinicians critical information to help make early decisions in the treatment regimen and increase chances of patient survival. CellSight is partnering with pharma and academia on various projects to validate this critically needed immune response monitoring tool as immunotherapies and combinational therapies are showing great promise. The sheer number of combinations are staggering yet there are no blood biomarkers or imaging tools available that can be predictive of responders versus nonresponders. Even if accurate blood biomarkers were to became available in the near future, whole body imaging will still be critically needed to determine local immune response site by site in the metastatic patient who are the ones being administered immunotherapies. Clinical symptoms during immunotherapy are very perplexing, as it might seem a patient is progressing when in fact their immune system is actively fighting the cancer or there might be a delay before immune response is apparent through traditional measures. An immune response monitoring tool, such as VisAcT, will be key in enabling success for immunotherapies. VisAcT was first discovered and developed in the Gambhir lab (Chair of Radiology at Stanford) and is exclusively licensed to CellSight. CellSight has obtained an IND primarily through funding from the NCI. We are currently conducting Phase 1 clinical trials at University of California San Francisco for various solid tumors including Melanoma, Lung and Bladder under Drs, Daud, Gubens and Fong respectively and are about to launch a Head/Neck cancer trial at Stanford under Dr. Colevas. Our primary target market is the immuno-oncology market however since the tracer shows immune response that is specific to activated T cells it can be useful for other immune modulated diseases such as Graft vs Host Disease and Rheumatoid Arthritis.